US Drug Recall Register
Class II · Moderate risk Terminated Initiated Apr 3, 2018 (8 years ago)

Orkambi 200 mg/125 mg Tablets #112 NDC 51167-0809-01 28 days supply.

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Processing Controls.

What was recalled

Orkambi 200 mg/125 mg Tablets #112 NDC 51167-0809-01 28 days supply.

Recalling firm
Kroger Specialty Pharmacy, Inc.
NDC code
51167-0809-01
Origin
MS, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0750-2018

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.